About this trial
Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.
Eligibility criteria
Qualifiers
Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months
Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness
Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)
Health insurance of any type
Disqualifiers
Prior treatment for OSA in past year
Central sleep apnea or narcolepsy
Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)
Heart failure with reduced ejection fraction of </= 45%
Trial design
Treatments tested in this trial
- Positive airway pressure (PAP) therapy
- Sleep dental device
- Atomoxetine-oxybutynin
Treatment groups
Sponsors and collaborators
Sairam Parthasarathy
Lead sponsor
University of Arizona
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
University of Arizona
Collaborator
University of Maryland
Collaborator
University of Miami
Collaborator
Stanford University
Collaborator